Lotus Prophy Angle

FDA 510(k) K220346 · Ajk Engineering, Inc.

Substantially Equivalent

510(k) numberK220346

Submission

Device name
Lotus Prophy Angle
Applicant
Ajk Engineering, Inc.
Sommerville, SC, US
Received
February 7, 2022
Decision date
November 7, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EGS – Handpiece, Contra- And Right-Angle Attachment, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4200
Specialty
Dental

Other 510(k)s with product code EGS

510(k)DeviceApplicantDecision
K251869Disposable Prophy Angle (3399-60, 3399-090, 3399-105)EGS · Traditional Premium Plus (Dongguan) Limited09/15/2025SE
K240950Disposable Prophy AngleEGS · Abbreviated Pacific Care Limited05/28/2025SE
K240183Star E900 Handpiece SeriesEGS · Traditional Dentalez, Inc., Stardental Division09/19/2024SE
K230106General Cutting StraightEGS · Traditional Nakanishi, Inc.05/24/2023SE
K222518FX ContraEGS · Traditional Nakanishi, Inc.11/17/2022SE
K220874Smooth Drive contra angle and straight handpiecesEGS · Traditional Lares Research11/07/2022SE
K220577Dental Handpiece, Model CA160, CA160L, and CA500LEGS · Traditional Micro-Nx Co., Ltd.07/29/2022SE
K213139SURGmatic S15 L ProEGS · Traditional Kavo Dental GmbH12/21/2021SE
K202960General Cutting Contra HandpieceEGS · Special Nakanishi, Inc.10/27/2020SE
K182892TRAUS Dental HandpiecesEGS · Traditional Saeshin Precision Co., Ltd.11/26/2019SE

Questions and answers

When was Lotus Prophy Angle cleared by the FDA?

Lotus Prophy Angle (K220346) received a 510(k) decision of Substantially Equivalent on November 7, 2022, 273 days after the submission was received.

What is the product code of K220346?

The FDA product code is EGS – Handpiece, Contra- And Right-Angle Attachment, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.